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临床试验/NCT00921102
NCT00921102已完成4 期

Intrathecal Atropine to Prevent Nausea and Vomiting After Spinal Anesthesia With Morphine for Elective Caesarean Section: a Randomized Controlled Trial

University of Parma2 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
216
试验地点
2
主要终点
Incidence of postoperative nausea and vomiting (PONV) as expressed by at least one rating > 3 on a numerical rating scale (0-10).

研究概览

简要总结

The aim of this study is to assess the efficacy of atropine in preventing nausea and vomiting after spinal anesthesia with local anesthetic and morphine for elective Caesarean section.

Patients enrolling in the study will be assigned to one of three groups. One will receive a small dose of intrathecal atropine; another will receive small-dose intravenous atropine; the third group will receive placebo.

详细描述

Intrathecal (IT) morphine grants effective, durable and safe analgesia after Caesarean section. The most common adverse effects after IT morphine are widespread pruritus and postoperative nausea and vomiting (PONV).

Postoperative nausea and vomiting is multifactorial in origin; in addition to general and pre-existing risk factors, such as elevated gonadotropin and progesterone serum levels, parturients undergoing Caesarean section are exposed to drug-induced, hemodynamic and surgical (manipulation of the uterus) stimuli.

Anticholinergic agents, and particularly scopolamine, have long been known to decrease opioid-related nausea and vomiting, although their narrow therapeutic range and inconvenient route of administration (typically transdermal) has limited their application. Anticholinergic agents are thought to act via inhibition of muscarinic receptors in several regions of the medulla oblongata, which are implicated with nausea and vomiting generation; in addition to the chemoceptor trigger zone, these receptors are particularly concentrated in, but not limited to the nucleus tractus solitarius. Cholinergic receptors have been typically associated with motion sickness, but cholinergic agonists such as neostigmine have been shown to increase the incidence of PONV, especially when injected intrathecally.

Anticholinergic agents with muscarinic selectivity may be effective in preventing and treating PONV. Intravenous (IV) administration of scopolamine or atropine, but not glycopyrrolate, reduces the incidence of PONV. Intuitively, as glycopyrrolate does not cross the blood-brain barrier, most postoperative anti-emetic effects of anticholinergic drugs should be mediated by central receptors.

Few studies have specifically evaluated the antiemetic effect of IV atropine after balanced general or opioid-based regional anesthesia, with conflicting results. Atropine may represent a valid alternative to scopolamine and its adverse effects; however, its apparent duration of action is "brief" (minutes to 1 hour) when administered IV.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients scheduled for elective Cesarean section at up to 42 weeks and 2 days
  • Patients in ASA Physical Status Class I or II
  • Informed written consent to participation
  • No known gestosis

排除标准

  • Any known fetal pathology
  • Indication to general anesthesia
  • Known allergy to any of the study drugs
  • Baseline bradycardia or any cardiovascular disease

研究组 & 干预措施

Control

Placebo Comparator

Patients in this group will receive both an intrathecal and intravenous injection of saline solution, as a placebo comparator.

干预措施: Bupivacaine (Drug)

Control

Placebo Comparator

Patients in this group will receive both an intrathecal and intravenous injection of saline solution, as a placebo comparator.

干预措施: Morphine (Drug)

Control

Placebo Comparator

Patients in this group will receive both an intrathecal and intravenous injection of saline solution, as a placebo comparator.

干预措施: Isotonic saline solution (Drug)

Intrathecal Atropine

Experimental

Patients in this group will receive intrathecal atropine as a prophylactic antiemetic agent. They will also receive intravenous saline solution to maintain blinding.

干预措施: Bupivacaine (Drug)

Intrathecal Atropine

Experimental

Patients in this group will receive intrathecal atropine as a prophylactic antiemetic agent. They will also receive intravenous saline solution to maintain blinding.

干预措施: Morphine (Drug)

Intrathecal Atropine

Experimental

Patients in this group will receive intrathecal atropine as a prophylactic antiemetic agent. They will also receive intravenous saline solution to maintain blinding.

干预措施: Isotonic saline solution (Drug)

Intrathecal Atropine

Experimental

Patients in this group will receive intrathecal atropine as a prophylactic antiemetic agent. They will also receive intravenous saline solution to maintain blinding.

干预措施: Atropine (Drug)

IV Atropine

Active Comparator

Patients in this group will receive a small dose of atropine via the intravenous route to examine its possible antiemetic activity. They will also receive intravenous saline solution to maintain blinding.

干预措施: Bupivacaine (Drug)

IV Atropine

Active Comparator

Patients in this group will receive a small dose of atropine via the intravenous route to examine its possible antiemetic activity. They will also receive intravenous saline solution to maintain blinding.

干预措施: Morphine (Drug)

IV Atropine

Active Comparator

Patients in this group will receive a small dose of atropine via the intravenous route to examine its possible antiemetic activity. They will also receive intravenous saline solution to maintain blinding.

干预措施: Isotonic saline solution (Drug)

IV Atropine

Active Comparator

Patients in this group will receive a small dose of atropine via the intravenous route to examine its possible antiemetic activity. They will also receive intravenous saline solution to maintain blinding.

干预措施: Atropine (Drug)

结局指标

主要结局

Incidence of postoperative nausea and vomiting (PONV) as expressed by at least one rating > 3 on a numerical rating scale (0-10).

时间窗: 12 hours post-operatively

次要结局

  • Incidence and prevalence of PONV up to 24 h postoperatively, expressed as both ratings on a numerical rating scale and as the area under the curve of these ratings over time.(Up to 24 h postoperatively)
  • Incidence of atropine-related side effects such as xerostomia, anxiety, tachycardia.(Up to 24 h postoperatively)
  • Postoperative pain expressed as time to first request for supplemental analgesia and as rating on a numerical rating scale.(Up to 24 h postoperatively)

研究者

申办方类型
Other

研究点 (2)

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